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Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01646671
First received: July 18, 2012
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will assess the safety, tolerability, and efficacy of LCZ696 in severe hypertensive patients


Condition Intervention Phase
Severe Hypertension
 Drug: LCZ696
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Patients With Severe Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Summarize the overall report of adverse event, serious adverse events including death, discontinuation due to adverse events, and notable laboratory abnormalities.


Secondary Outcome Measures:
  • Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) at week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Sitting BP measurements will be performed at screening through the end of study at every visit. Four separate sitting BP will be obtained with a full two-minute interval between measurements.

  • Percentage of patients with successful blood pressure (BP) control rate in msSBP/msDBP at endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful control rate is defined as msSBP/msDBP< 140/90 mmHg at endpoint

  • Percentage of patients achieving a successful msSBP control at endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A successful msSBP control is defined as msSBP <140 mmHg at endpoint

  • Percentage of patients achieving a successful msDBP control at endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A successful BP control is defined as msDBP <90 mmHg at endpoint

  • Percentage of patients achieving a successful response rate in msSBP [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate in msSBP is defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline

  • Percentage of patients achieving a successful response rate in msDBP [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate in msDBP is defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline


Enrollment: 38
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCZ696
Patients will be started from LCZ696 200 mg (once daily), and will be titrated over LCZ696 400 mg (once daily) based on patients' blood pressure and integrated condition.Another class of antihypertensive drug (other than ARB, ACEi, or fixed combination containing ARB or ACEi) can be added or dose of concomitant antihypertensive drug can be increased if patients are already on LCZ696 400mg and blood pressure is not controlled according to protocol description. Patients, who are already on LCZ696 400 mg dose, should not change the LCZ696 dose.
 Drug: LCZ696
LCZ696 200mg tablet once daily

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

Exclusion Criteria:

  • Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mH
  • History of angioedema, drug-related or otherwise, as reported by the patient
  • Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
  • Patients have significant cardiovascular co-morbidities
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646671

Locations
Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 231-0023
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-0031
Novartis Investigative Site
Hachioji-city, Tokyo, Japan, 192-0918
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 108-0075
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-7390
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 143-0023
Novartis Investigative Site
Shibuya-ku, Tokyo, Japan, 150-0002
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 141-0032
Novartis Investigative Site
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01646671     History of Changes
Other Study ID Numbers: CLCZ696A1305
Study First Received: July 18, 2012
Last Updated: February 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Hypertension, Severe, LCZ696

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013